NCT07567027 · NYU Langone Health
Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)
What this study is about
The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.
View original scientific description
The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.
Interventions
DEVICE
Barrigel Injectable Gel
Barrigel is a hyaluronic acid-based absorbable perirectal spacer.
PROCEDURE
Cryoablation
Minimally invasive treatment for both localized and recurrent prostate cancer.
Primary outcome measures
Percentage of cases in which Barrigel remains unfrozen (temperature maintained above 0°C throughout the freeze cycles)
Time frame: End of procedure (up to 4 hours)
Barrigel freeze will be defined as a measured temperature ≤ 0°C within or immediately adjacent to the gel, or ultrasound evidence of ice formation within the gel volume. Thermal stability will therefore be expressed as the percentage of procedures in which Barrigel resists freezing under standard cryoablation conditions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male patients aged 40-95 years.
- Biopsy-confirmed localized prostate cancer (Grade Group ≥ 2). Salvage cryoablation cases may be included.
- Unifocal disease visible on multiparametric MRI (mpMRI) and amenable to focal or whole gland cryoablation.
- Prostate-specific antigen (PSA) \< 20 ng/ml.
- No metastatic disease on Prostate-Specific Membrane Antigen (PSMA) PET/CT, when recommended per National Comprehensive Cancer Network (NCCN) guidelines.
- Eligible for and consenting to transperineal cryoablation under anesthesia.
- Willingness to comply with post-procedure follow-up, including PSA testing and imaging.
- Cryoablation which requires treatment of the posterior prostate as per clinician judgement.
Exclusion criteria
- Evidence of metastatic disease.
- Prior radiation therapy to the area of the prostate.
- Active rectal or urinary tract infection.
- Known allergy to hyaluronic acid products or contrast agents.
- Inability to tolerate MRI.
- Inability or unwillingness to comply with study follow-up.
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations